CHICAGO, June 23 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced that a second non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin), showed that a 14-day course of Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax. All of the animals in the study that received 16 mg/kg once-a-day (the human equivalent dose of 300 mg) of Restanza within 24 hours after exposure to anthrax survived while none of the animals that received placebo survived. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), which is a component of the Department of Health and Human Services (HHS), an agency of the U.S. Government.
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“The successful outcome of the study provides strong evidence of Restanza’s life saving potential and underscores its value as a potent new biodefense countermeasure,” said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. “When coupled with the positive outcome of the pivotal primate study that we announced in May 2007, we believe that these significant findings complete the regulatory package for Restanza in the post-exposure prophylactic treatment of inhalation anthrax indication. We are looking forward to working with NIAID on the final study report and submitting our data package for regulatory review based on our NDA for Restanza, which is currently under review by the FDA for the treatment of mild-to-moderate community acquired pneumonia (CAP).”
Restanza as a Biodefense Countermeasure
Advanced Life Sciences is developing Restanza for the post-exposure prophylactic treatment of inhalation anthrax to help protect against human infection from anthrax. In studies conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Restanza was shown to be highly active in vitro against 30 strains of anthrax. In May 2007, a non-human primate study showed that a 30-day course of oral Restanza was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.
In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.
FDA’s “Animal Efficacy Rule” and the Use of Non-Human Primates
The “Animal Efficacy Rule” allows for approval of new drug products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the “Animal Efficacy Rule” is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product’s approval was based on efficacy studies conducted in animals alone.
The non-human primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to FDA’s “Animal Efficacy Rule” (21 C.F.R. Section 314.600-650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. For more information, please visit us on the web at www.advancedlifesciences.com
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
CONTACT: Joe Camp of Advanced Life Sciences, +1-630-754-4352,
jcamp@advancedlifesciences.com
Web site: http://www.advancedlifesciences.com/
